- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04681911
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
A Phase II Single-arm Clinical Trial of Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Jianli Zhao
- Phone Number: 86-20-34070870
- Email: zhaojli5@mail.sysu.edu.cn
Study Contact Backup
- Name: Ying Wang
- Phone Number: 86-20-34070499
- Email: wangy556@mail.sysu.edu.cn
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510000
- Recruiting
- Sun Yat Sen Memorial Hospital,Sun Yat sen University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Subjects must meet all of the following conditions:
- Adult female patients (age 18-70 years) with metastatic breast cancer confirmed by pathology or imaging;
- Pathological diagnosis of HER-2 was positive (definition: immunohistochemical results were + + + or in situ hybridization results were positive);
- Received trastuzumab treatment in the past;
- the patients have received 1-3 treatments for metastatic breast cancer in the past;
- According to RECIST 1.1, patients with at least one target lesion or simple bone metastasis can be evaluated;
- ECoG score of physical status was less than 2, and the expected survival time was not less than 3 months;
- Prior treatment-related toxicity should be reduced to NCI CTCAE (version 5.0) ≤ 1 degree (except for hair loss or other toxicity which is considered as no risk to patient's safety according to the investigator's judgment) 8)LVEF≥50%;
9) Sufficient functional reserve of bone marrow
- White blood cell count (WBC) ≥ 3.0 × 10 ^ 9 / L,
- Neutrophil count (ANC) ≥ 1.5 × 10 ^ 9 / L,
- Platelet count (PLT) ≥ 100 × 10 ^ 9 / L 10) Previous treatment-related toxicity should be relieved as NCI CTCAE (version 5.0) ≤ 1 degree, total bilirubin (TBIL) ≤ 1.5 × upper limit of normal value (ULN), alanine aminotransferase (ALT / AST) ≤ 2.5 × ULN (liver metastasis patients ≤ 5xuln), serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 60 ml / min; 11) Be able to understand the research process, volunteer to participate in the study, and sign informed consent.
Exclusion Criteria:
Subjects were not allowed to participate in the study if they had any of the following conditions:
- No trastuzumab treatment was received;
- Have received more than 3 therapeutic regimens for metastatic breast cancer;
- No treatment for metastatic breast cancer was received;
- Patients who are known to be allergic to active or other components of the study drug.
- They received radiotherapy, chemotherapy, endocrine therapy within 4 weeks before enrollment, or were participating in any clinical trials of intervention drugs;
- Pregnant or lactating women, women of childbearing age who refused to take effective contraceptive measures during the study period.
- Any other situation in which the researcher considers that the patient is not suitable for the study may interfere with the concomitant diseases or conditions involved in the study, or there are any serious medical barriers that may affect the safety of the subjects (e.g., uncontrollable heart disease, hypertension, active or uncontrollable infection, active hepatitis B virus infection)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Inetetamab Combined With Pyrotinib and Chemotherapy
Inetetamab: 8mg/kg for the first dose, 6mg/kg for the following doses, every 3 weeks for one cycle. Pyrotinib: 400mg, oral, every day. Chemotherapy: the choice of physicians,as the following regimens: Capecitabine, 1000 mg/m2, d1-d14, 3-week cycle Gemcitabine, 1000 mg/m2, D1, D8, 3-week cycle Vinorelbine, 25-30 mg/m2, D1, D8, 3-week cycle Carboplatin, AUC = 6, 3-week cycle Albumin paclitaxel, 100 mg/m2, weekly Eribulin, 1.4 mg/m2, D1, D8, 3-week cycle |
Inetetamab: 8mg/kg for the first dose, 6mg/kg for the following doses, every 3 weeks for one cycle.
Pyrotinib: 400mg, oral, every day.
Capecitabine, 1000 mg/m2, d1-d14, 3-week cycle
Other Names:
Gemcitabine, 1000 mg/m2, D1, D8, 3-week cycle
Other Names:
Vinorelbine, 25-30 mg/m2, D1, D8, 3-week cycle
Other Names:
Carboplatin, AUC = 6, 3-week cycle
Other Names:
Albumin paclitaxel, 100 mg/m2, weekly
Other Names:
Eribulin, 1.4 mg/m2, D1, D8, 3-week cycle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate,ORR
Time Frame: 18 weeks after enrollment
|
Objective response rate assessed at 18 weeks after enrollment,that is about 6 cycles of treatment
|
18 weeks after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival,PFS
Time Frame: 2 years
|
The time from the beginning of treatment to the progression or death of the patient
|
2 years
|
overall survival,OS
Time Frame: 4 years
|
The time from the beginning of treatment to the death of the patient
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4 years
|
Clinical Benefit Rate,CBR
Time Frame: 24 weeks after enrollment
|
Clinical Benefit Rate assessed at 24 weeks after enrollment,that is about 8 cycles of treatment
|
24 weeks after enrollment
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the rate of adverse events
Time Frame: up to 24 weeks after enrollment
|
The probability and severity of adverse reactions were analyzed up to 24 weeks after enrollment
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up to 24 weeks after enrollment
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Quality of life scale score,QoL
Time Frame: 1 year
|
The quality of life score of patients during treatment was analyzed(FACT-B).
Performance Status Rating (PSR) was demonstrated for the FACT-B total score, which is the result of the following subscale scores: SWB (the Social / family Well-Being subscale) , EWB (the Emotional Well-Being subscale), AC (Additional Concerns subscale), PWB (the Physical Well-Being subscale), FWB (the Functional Well-Being subscale)
|
1 year
|
Exploration of biomarkers
Time Frame: the first week after the enrollment
|
Objective to explore the correlation between biomarkers and the ORR.
The biomarkers will be test by nest-generation sequence, which include 520 genes and tumor mutation burden, like ERBB2/TP53/PIK3CA/ERBB4/CCND1 and so on.
|
the first week after the enrollment
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Collaborators and Investigators
Investigators
- Principal Investigator: Jianli Zhao, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Publications and helpful links
General Publications
- Li X, Yang C, Wan H, Zhang G, Feng J, Zhang L, Chen X, Zhong D, Lou L, Tao W, Zhang L. Discovery and development of pyrotinib: A novel irreversible EGFR/HER2 dual tyrosine kinase inhibitor with favorable safety profiles for the treatment of breast cancer. Eur J Pharm Sci. 2017 Dec 15;110:51-61. doi: 10.1016/j.ejps.2017.01.021. Epub 2017 Jan 21.
- Ma F, Ouyang Q, Li W, Jiang Z, Tong Z, Liu Y, Li H, Yu S, Feng J, Wang S, Hu X, Zou J, Zhu X, Xu B. Pyrotinib or Lapatinib Combined With Capecitabine in HER2-Positive Metastatic Breast Cancer With Prior Taxanes, Anthracyclines, and/or Trastuzumab: A Randomized, Phase II Study. J Clin Oncol. 2019 Oct 10;37(29):2610-2619. doi: 10.1200/JCO.19.00108. Epub 2019 Aug 20.
- Ma F, Li Q, Chen S, Zhu W, Fan Y, Wang J, Luo Y, Xing P, Lan B, Li M, Yi Z, Cai R, Yuan P, Zhang P, Li Q, Xu B. Phase I Study and Biomarker Analysis of Pyrotinib, a Novel Irreversible Pan-ErbB Receptor Tyrosine Kinase Inhibitor, in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer. J Clin Oncol. 2017 Sep 20;35(27):3105-3112. doi: 10.1200/JCO.2016.69.6179. Epub 2017 May 12.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Gemcitabine
- Carboplatin
- Paclitaxel
- Capecitabine
- Vinorelbine
Other Study ID Numbers
- 2020-KY-125
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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